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Apr 14, 2026
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
Apr 14, 2026
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
Apr 14, 2026
The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.
Apr 14, 2026
Daraxonrasib showed median overall survival of 13.2 months versus 6.7 months for chemotherapy in a Phase III trial in previously treated metastatic pancreatic adenocarcinoma. The once-daily pan-RAS(ON) inhibitor was generally well tolerated, and the company plans to seek FDA approval.
Apr 14, 2026
The FDA cleared MiniMed Flex, a screen-free insulin pump controlled by smartphone, and granted breakthrough device designation to Portal Diabetes’ implantable Portal Pump system. Portal Diabetes also began a Phase I study of Portal Insulin, while MiniMed said Flex supports its latest algorithm, sensors and infusion sets.
Apr 14, 2026
The FDA reminded more than 2,200 sponsors and researchers to submit required clinical trial results and said 29.6% of likely reportable studies lacked posted results. It also issued warning letters over CGMP violations at a contract manufacturer and protocol failures that led to excessive dosing in a clinical study.
Apr 13, 2026
PharmaMar and Globant deployed a multi-agent AI framework to accelerate oncology drug discovery. The system delivers over 90% accuracy in data retrieval and generates insights up to 15 times faster.
Apr 13, 2026
Arecor said it is in talks on a broader AT278 partnership as it targets a phase II trial start in the second half of 2026. The company also cited FDA feedback, Ligand financing and year-end cash of £6.1 million.
Apr 13, 2026
The FDA has cleared the Onclarity HPV Self-Collection Kit for at-home use, with availability by prescription expected in the coming months. A JAMA Network Open study found 61% of women still prefer clinic screening, while 20% prefer self-sampling at home.
Apr 12, 2026
Invivyd reported progress in the Phase 3 DECLARATION trial of VYD2311, with top-line data now expected in Q3 2026 after a sample size increase of about 500 subjects. The company also aligned with the FDA on the LIBERTY Phase 3 study, a pediatric study plan for DRUMMER, and advanced measles antibody candidate VMS063.
Apr 12, 2026
Puma Biotechnology reported quarterly revenue of $75.50 million and EPS of $0.26, above consensus estimates. The company also guided for 2026 total revenue of US$214 million to US$221 million and net income of US$10 million to US$13 million.
Apr 12, 2026
The global API market is projected to grow to USD 198.39 billion by 2030 from USD 144.20 billion in 2025, at a 6.6% CAGR. Oncology, rare disease and diabetes pipelines are key growth drivers.
Apr 11, 2026
Pharma robots and clean room pass-through systems are projected to grow through 2035 as drugmakers increase automation and contamination control. Demand is being driven by biologics, cell and gene therapies, stricter sterile-manufacturing requirements, and investment in cleanroom infrastructure.
Apr 11, 2026
Orbicular and Apotex received tentative U.S. FDA approval for a generic Ozempic semaglutide injection. Apotex will commercialize the product in the United States as the ANDA applicant.
Apr 11, 2026
Bristol Myers Squibb said 2025 revenue was flat as a 17% increase in growth-portfolio sales offset a 15% decline in legacy drugs. The company expects legacy sales to fall another 12-16% in 2026, with newer products such as Opdivo, Reblozyl and Breyanzi supporting results.
Apr 11, 2026
Q1 2026 sleep medicine trends include broader use of AI, expanding obstructive sleep apnea and narcolepsy treatments, and policy changes affecting reimbursement and access.
Apr 11, 2026
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
Apr 11, 2026
The REMEDY Act would limit the Hatch-Waxman Act’s 30-month stay to one Orange Book-listed patent and require that patent to be designated in advance. The bill was reintroduced in the Senate on July 31, 2025 and is again in committee.
Apr 11, 2026
FDA debate over clinical trial reform is focused on continuous trials and faster, risk-based pathways for low-risk studies. Recent FDA remarks and existing guidance frame adaptive, seamless designs as compliant if trial integrity is maintained.
Apr 11, 2026
The FDA approved Endospan’s NEXUS Aortic Arch Stent Graft, enabling US commercial launch. Approval was supported by one-year TRIOMPHE study results in high-risk surgical patients.
